NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass

NCT02128516 | Completed

• 1 other identifier: CEN1118
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an intermediate profile, rich in leucines and other essential amino acids, can significantly enhance muscle mass gain during strength training. This study will compare the efficacy of NUTRALYS® to a reference product. If the results of the study demonstrate a significant improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be considered as an alternative to sports nutrition products, to which many people are intolerant.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Biceps brachial thickness measured using ultrasonography

  biceps muscle thickness measured in millimeter using images from ultrasonography

  12 weeks after first ingestion

Secondary Outcomes (5)

• Elbow flexor strength

  12 weeks after first ingestion

• Biceps circumference

  12 weeks after first ingestion

• body weight

  12 weeks after first ingestion

• tolerance

  12 weeks after first ingestion

• muscle force

  12 weeks after first ingestion

Study Arms (3)

whey protein

ACTIVE COMPARATOR

whey protein

Other: oral powder in sachet

placebo

PLACEBO COMPARATOR

placebo

Other: oral powder in sachet

pea protein

EXPERIMENTAL

pea protein

Other: oral powder in sachet

Interventions

oral powder in sachet OTHER

Also known as: Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide)

pea protein; placebo; whey protein

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects from 18 to 35 years of age:
• engaged in moderate or occasional sports activity;
• having given their written informed consent;
• in gainful employment or a student;
• in possession of a medical certificate of fitness for sports

You may not qualify if:

• Subject already engaged in regular sports or training increasing muscle strength or volume in the upper limbs and particularly the biceps brachial;
• Subject engaged or having engaged in the last 6 months in weight training more than once a week;
• Subject having had a muscle injury in the 3 months prior to the study;
• Asthmatic subject liable to be administered corticosteroids;
• Subject taking part in another trial;
• Subject with a known hypersensitivity to whey or pea proteins;
• Subject deprived of their freedom for administrative, medical or legal reasons or not in possession of the legal or ethical capacity to enter into a contract due to cognitive function impairment;
• Subject liable not to comply with the constraints required by the protocol;
• Subject not covered by health insurance;
• Subject having taken in the previous month or currently taking: medication, a dietary supplement, sports drink, food for particular nutritional uses or functional foods, of any kind, liable or described as liable to increase physical performance and notably to increase muscle mass;
• Subject taking anabolic protein or corticosteroid treatment;
• Subject on a high-protein diet.

Sponsors & Collaborators

• Nicolas Babault: lead
• Roquette Freres: collaborator

Study Sites (1)

Centre d'Expertise de la Performance

Dijon, 21078, France

Location

Related Publications (1)

• Babault N, Paizis C, Deley G, Guerin-Deremaux L, Saniez MH, Lefranc-Millot C, Allaert FA. Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein. J Int Soc Sports Nutr. 2015 Jan 21;12(1):3. doi: 10.1186/s12970-014-0064-5. eCollection 2015.

  PMID: 25628520 DERIVED

MeSH Terms

Interventions

Powders; Whey; Aspartame; Salts

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Inorganic Chemicals

Study Officials

• Francois A Allaert, MD

  CEN Nutriment

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific and sports coordinators

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 1, 2014
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

FR (1)